May 4, 2016
Recommended Topic Related To:

Betapace AF

"The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product appr"...

A A A

Betapace AF

BETAPACE® AF
(sotalol hydrochloride) Tablets, USP




To minimize the risk of induced arrhythmia, patients initiated or reinitiated on sotalol hydrochloride tablets should be placed for a minimum of three days (on their maintenance dose) in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Creatinine clearance should be calculated prior to dosing. For detailed instructions regarding dose selection and special cautions for people with renal impairment, see DOSAGE AND ADMINISTRATION. Sotalol is also indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm and is marketed under the brand name Betapace AF®. Sotalol hydrochloride tablets, USP are not approved for the AFIB/AFL indication and should not be substituted for Betapace AF because only Betapace AF is distributed with a patient package insert that is appropriate for patients with AFIB/AFL.

DRUG DESCRIPTION

Sotalol hydrochloride tablets, USP are an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. It is supplied as a white to off-white, capsule-shaped, scored tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N203S•HCl and is represented by the following structural formula:

 Betapace-AF (Sotalol hydrochloride) Structural Formula Illustration

Each tablet, for oral administration, contains 80 mg, 120 mg, 160 mg or 240 mg of sotalol hydrochloride. In addition, each tablet also contains the following inactive ingredients: magnesium stearate and microcrystalline cellulose.

What are the possible side effects of sotalol AF (Betapace AF, Sotalol Hydrochloride AF)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
  • feeling like you might pass out;
  • slow heartbeats;
  • trouble breathing;
  • unusual sweating, increased thirst; or
  • swelling, rapid weight gain.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Betapace AF »

What are the precautions when taking sotalol hcl (Betapace AF)?

See also Warning section.

Before taking sotalol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain heart rhythm problems (such as a slow heartbeat, second- or third-degree atrioventricular block unless you have a heart pacemaker), severe heart failure, breathing problems (such as asthma, chronic bronchitis, emphysema).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney...

Read All Potential Precautions of Betapace AF »

Last reviewed on RxList: 2/1/2016
This monograph has been modified to include the generic and brand name in many instances.

Betapace AF - User Reviews

Betapace AF User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Betapace AF sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.

Atrial Fibrillation Quiz